Integrated Health Care for PTSD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yoga and meditation, Wellness, Positive affect, Information.
- Who it may be relevant to
- Registry conditions: Posttraumatic Stress Disorder (PTSD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Hybrid I Evaluation of Integrative Health Care for PTSD
Overview
The goal of this clinical trial is to determine whether which types of integrative care, meaning a combination of psychotherapy and mind-body interventions, lead to the most changes in functioning among Veterans with posttraumatic stress disorder (PTSD). The main aims are: 1. To evaluate the impact of integrative care approaches on functional outcomes among Veterans with PTSD. 2. To examine factors relevant to the implementation of integrated treatments for PTSD from the perspective of patients, providers and administrators in the VA Healthcare System. Participants will: 1. Complete assessments at the beginning of the study and 12- and 24-weeks later. 2. Engage in 12 weeks of integrated care, with the type being randomly assigned.
Interventions
- Behavioral Yoga and meditation
12 weekly 60-minute hatha yoga classes and access to video-based training in a portable mantra-based meditation practice - Behavioral Wellness
12 weekly 60-minute classes to provide education about exercise and nutrition and facilitate lifestyle changes - Behavioral Positive affect
12 weekly 60-minute classes to teach strategies for increasing positive affect and to provide social connection - Other Information
Provision of written information about local and national complementary and integrative care resources
Primary outcome measures
- Inventory of Psychosocial Functioning (IPF) [Time frame: weeks 0, 12 and 24]
Secondary outcome measures (3)
- Clinician Administered PTSD Scale for DSM-5 Revised (CAPS-5R) [Time frame: weeks 0, 12 and 24]
- Quick Inventory of Depressive Symptomatology (QIDS) [Time frame: weeks 0, 12 and 24]
- Insomnia Severity Index (ISI) [Time frame: weeks 0, 12 and 24]
Eligibility criteria
Inclusion criteria
- clinical diagnosis
- eligibility for Cognitive Processing Therapy (CPT) at a participating VA site
- able to consent to study activities
Exclusion criteria
- current, active engagement in one of the included approaches (per clinician judgment)
- medical conditions that contraindicate engaging in the experimental interventions
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 5 centers
- VA Central Arkansas Healthcare System — Little Rock
- VA San Diego Healthcare System — San Diego
- Durham VA Healthcare System — Durham
- VA Portland Healthcare System — Portland
- VA North Texas Healthcare System — Dallas
Identifiers
NCT: NCT07220681 · HT94252510881